Data / Medical devices / United States / Caldera Medical, Inc.
Caldera Medical, Inc.: FDA-registered device maker in Westlake Village, CA, United States, 26 510(k) clearances
Caldera Medical, Inc. is registered with the FDA (registration 3003990090) in Westlake Village, CA, United States. It lists 8 device types. The FDA files 26 510(k) clearances under its listings, the newest dated November 30, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003990090
- Address
- 4360 Park Terrace Drive, Westlake Village, CA, United States, 91361
- Owner or operator
- Caldera Medical (10028052)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 4, 2013
- Registered through
- 2026
- Brand names listed
- Benesta Hysteroscope, Benesta Max Tissue Removal Device, 1/BX, Benesta Max Tissue Removal Device, 1/BX + Outflow Tubing, 1/BX, Benesta Outflow Tubing, 1/BX, Benesta Outflow Tubing, 10/BX, Benesta Plus Tissue Removal Device, 1/BX, Benesta Plus Tissue Removal Device, 1/BX + Outflow Tubing, 1/BX, Benesta Pro Tissue Removal Device, 1/BX and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 30, 2023 | K233500 | Benesta Tissue Removal Device | HIH | Substantially Equivalent | Caldera Medical, Inc. | accessdata.fda.gov |
| November 10, 2021 | K211975 | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System | OTN | Substantially Equivalent | Caldera Medical, Inc. | accessdata.fda.gov |
| June 30, 2021 | K210512 | LUMINELLE DTx System | FAJ | Substantially Equivalent | Uvision360, Inc. | accessdata.fda.gov |
| October 23, 2020 | K192811 | BenestaTM Tissue Removal Device | HIH | Substantially Equivalent | Caldera Medical, Inc. | accessdata.fda.gov |
| September 17, 2020 | K201686 | GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT Introducer and Catheter Guide, GYNECARE TVT EXACT Continence System and Trocar, GYNECARE TVT Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide | OTN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| September 9, 2020 | K192822 | Benesta Hysteroscope | HIH | Substantially Equivalent | Caldera Medical, Inc. | accessdata.fda.gov |
| July 20, 2020 | K193603 | Benesta Medical Sterilization Tray | KCT | Substantially Equivalent | Caldera Medical, Inc. | accessdata.fda.gov |
| February 7, 2020 | K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack | PAH | Substantially Equivalent | Caldera Medical, Inc. | accessdata.fda.gov |
| January 16, 2020 | K192357 | INNOVO | QAJ | Substantially Equivalent | Atlantic Therapeutics, Ltd. | accessdata.fda.gov |
| November 1, 2019 | K192278 | Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) | HIH | Substantially Equivalent | Uvision360, Inc. | accessdata.fda.gov |
| June 6, 2019 | K190827 | Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid | HIH | Substantially Equivalent | Uvision360, Inc. | accessdata.fda.gov |
| August 16, 2018 | K181909 | Luminelle DTx Hysteroscopy System | FAJ | Substantially Equivalent | Uvision360, Inc. | accessdata.fda.gov |
| August 10, 2018 | K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System | PWJ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| July 6, 2018 | K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar | PWJ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| June 28, 2018 | K173162 | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide | PWJ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| May 4, 2018 | K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left | PWJ | Substantially Equivalent | Caldera Medical, Inc. | accessdata.fda.gov |
| January 11, 2017 | K162201 | Desara TV, Desara Blue TV | OTN | Substantially Equivalent | Caldera Medical, Inc. | accessdata.fda.gov |
| April 6, 2015 | K150023 | Vertessa Lite Y-Mesh | OTO | Substantially Equivalent | Caldera Medical, Inc. | accessdata.fda.gov |
| April 6, 2015 | K150016 | Vertessa Lite | OTO | Substantially Equivalent | Caldera Medical, Inc. | accessdata.fda.gov |
| July 1, 2014 | K140843 | DESARA BLUE OV, DESARA BLUE SS | OTN | Substantially Equivalent | Caldera Medical | accessdata.fda.gov |
| September 23, 2013 | K132069 | DESARA MESH, DESARA BLUE | OTN | Substantially Equivalent | Caldera Medical, Inc. | accessdata.fda.gov |
| August 23, 2013 | K132054 | GYNECARE TVT EXACT CONTINENCE SYSTEM | OTN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| February 19, 2013 | K121928 | DESARA SL | OTN | Substantially Equivalent | Caldera Medical, Inc. | accessdata.fda.gov |
| July 1, 2010 | K100936 | GYNECARE TVT ABBREVO CONTINENCE SYSTEM | OTN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 16, 2010 | K100485 | GYNECARE TVT EXACT CONTINENCE SYSTEM | OTN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 8, 2003 | K033568 | GYNECARE TVT OBTURATOR SYSTEM | OTN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
- All makers of Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- All makers of Hysteroscope (And Accessories)
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Updated November 30, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.